You're a local P&T committee member. In the current resource-constrained healthcare environment and in order to provide quality care at a lower cost, one member recommends deleting the brand name Coumadin® (warfarin) in favor of a new A-rated generic warfarin. Another committee member argues against this change because it's a narrow therapeutic index (NTI) drug. He states the facility should continue to provide the brand name drug despite it's significantly higher cost solely because of this "narrow therapeutic index" moniker.

The discussion is over and it's time to vote. Switch to the A rated generic or stay with the brand name agent despite it's significantly higher cost? How do you vote? Why?

SELECT  here for discussion

Would recommend voting FOR the A rated generic. Here's some reasons why.

First, an explanation of A-rated generics. According to the FDA, "A" products are those for which actual or potential bioequivalence problems have been resolved with adequate in vivo and/or in vitro evidence supporting the generic products' bioequivalence. (FYI - "B" products, for which actual or potential bioequivalence problems have not been resolved by adequate evidence of bioequivalence, often have a problem with specific dosage forms rather than with the active ingredients.)

Some examples of organizations routinely using A-rated generics:

The DoD Pharmacy and Therapeutics (P&T) committee removed all "brand name only" designations from the Basic Core Formulary (BCF) when A-rated generic products became available. Examples include: carbamazepine [Tegretol®], warfarin [Coumadin®], digoxin [Lanoxin®], etc.

*    Current DoD pharmacy guidance (as well as many, if not most, civilian pharmacy benefit plans - see below) prescribes mandatory generic substitution. Generic drugs are less expensive to the system AND to the patient. (One article I saw states quality A-rated generic products in the US are even less expensive than generic or brand name agents in Canada!) In the TRICARE Mail Order Pharmacy (TMOP) and the TRICARE Retail Network Pharmacies (TRRx) venues ($3 generic co-pay vs $9 brand name co-pay). Providers may indicate "brand name necessary" on prescriptions to the TRRx and TMOP but are required to show "medical necessity" for such requests.

*    The FDA has published several letters (see hyperlinks below) regarding the equivalence of generic drugs, including NTI drugs.

*    Most state Medicaid programs also mandate mandatory generic substitution.

*    In a position paper, the Academy of Managed Care Pharmacy (AMCP) opposes legislation restricting the appropriate generic substitution of NTI drugs. (http://www.amcp.org/pf.ark?c=legislative&sc=position&id=11)

*    Indiana Medicaid board follows FDA guidance on generic substitution and makes no distinction for NTI drugs. A provider may specify and justify a "brand name necessary" request.

*    The Michigan, Texas, and Oklahoma Medicaid programs handle NTI drugs in a similar fashion.

FDA letter addressing NTI drugs (dated - 6 Feb 1998)  http://www.fda.gov/cder/news/ntiletter.htm - "....If one therapeutically equivalent drug is substituted for another, the physician, pharmacist, and patient have FDA's assurance that the physician should see the same clinical results and safety profile. Any differences that could exist should be no greater than one would expect if one lot of the innovator's product was substituted for another."

FDA's Center for Drug Evaluation and Research (CDER) - Office of Generic Drugs -http://www.fda.gov/cder/ogd/#Introduction

For more information on the safety and effectiveness of generic drugs, please see 

o    FDA White Paper: New FDA Initiative on "Improving Access to Generic Drugs." http://www.fda.gov/oc/initiatives/generics/whitepaper.html (6/12/2003).

o    FDA White Paper: Generic Drug Prices in the U.S. Are Lower Than Drug Prices in Canada http://www.fda.gov/oc/whitepapers/drugprices.html. (11/2003)

o    FDA and the Drug Development Process: How the Agency Ensures that Drugs are Safe and Effective (2/2002) http://www.fda.gov/opacom/factsheets/justthefacts/17drgdev.html or http://www.fda.gov/opacom/factsheets/justthefacts/17drgdev.pdf. 

o    FDA Ensures Equivalence of Generic Drugs http://www.fda.gov/cder/about/whatwedo/testtube-17.pdf. From the 1999 edition of "From Test Tube to Patient: Improving health through human drugs."

o    Generic Drugs:  Questions and Answers http://www.fda.gov/cder/consumerinfo/generics_q&a.htm  

o    Generic Drugs: Safe. Effective. FDA Approved.  Public service announcements promoting the safety and effectiveness of generic drugs. 

o    Six Public Service Announcements http://www.fda.gov/cder/consumerinfo/generic_info/default.htm  

o    What You Want to Know About Generic Drugs: Generic Drug Education Presentation http://www.fda.gov/cder/present/pas/FieldPAS.htm or PPT http://www.fda.gov/cder/present/pas/FieldPAS_files/FieldPAS.ppt. 

o    Consumer Education: What You Should Know About Buying and Using Drug Products -- Generic Drug Products http://www.fda.gov/cder/consumerinfo/DPAdefault.htm

This Pearl is meant for academic and educational purposes only. This Pearl is meant to raise important points regarding the safe and cost-effective pharmacotherapy of patients. It is not meant to be the definitive reference for the treatment or prophylaxis of various diseases. Although every effort is taken to ensure this Pearl is correct and factual, errors may occur. The US Air Force, the 59th Medical Wing (MDW), and 59th MDW Pharmacy assume no liability for incorrect information or harm that may occur from the use of the information included in this Pearl.